510(k) K253354
K253354 is an FDA 510(k) premarket notification submitted by Guangzhou Hehong Biotech Co., Ltd. for the device "Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)". The FDA issued a decision of Substantially Equivalent on February 12, 2026. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Guangzhou Hehong Biotech Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2026
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type